Treats seizures associated with Lennox-Gastaut Syndrome (LGS). ANDA 204964, held by Lupin. Rufinamide.
As of Nov 14, 2026, ANDA 204964 (Rufinamide), held by Lupin, was first approved by FDA on Aug 17, 2022, with 0 approved supplements and 0 published complete response letters.
Rufinamide tablets USP are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 17, 2022 | Original application | Approved |
| Rufinamide100MG · tablet;oral | Rufinamide | Rx |
| Rufinamide200MG · tablet;oral | Rufinamide | Rx |
| Rufinamide400MG · tablet;oral | Rufinamide | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
